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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04475991 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : June 4, 2022, 2 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 4, 2022, 2 p.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-17 |
|
Recruitment status
Last imported at : June 4, 2022, 2 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
inclusion criteria: with severe non-critical stage of covid at the time of admission. patients tested positive for sars-cov-2 confirmed by pcr (polymerase chain reaction) or quick antigen test within the first 12 days post appearance of symptoms with at least one of the following risk factors: diabetes mellitus (dm), obesity (bmi>30, hypertension, age > 65 years. respiratory rate 25-34/min and no signs of respiratory distress. with at least two of the following indicators of severity: spo2 81-90%, pafi 150-300 mmhg, fio2>60% , lung damage in thorax radiographic image => 25% as determined by rale score (an equivalent to 2-4). normal liver function (considered up to a fivefold increase above the normal limits of hepatic transaminases) signed informed consent |
|
Exclusion criteria
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
pregnant or lactating women patients already participating in another clinical study oxygen saturation < 70% (ambient) clinical evidence of an infectious disease different from covid at the time of admission chronic kidney failure coronary disease glomerular filtration rate < 30ml/min/1.73 m2 and known history of preexisting chronic renal failure (chronic kidney disease stages 4-5) known history of hcv, hbv and/or clinical signs of hepatic liver failure. any type of cancer hiv and/or any anti retroviral treatment inability to freely decide to participate psychotropics treatment erythromycin treatment polydrug use (defined as more than two addictions combined) with transplant background with any autoimmune disorder with known hypersensibility to maraviroc and/or favipiravir on invasive mechanical ventilation at the time of randomization |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Hospital General de México Dr. Eduardo Liceaga |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
70 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mexico |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : June 4, 2022, 2 p.m. Source : ClinicalTrials.gov |
19 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Patients free of mechanical ventilation or death |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 767, "treatment_name": "Maraviroc", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1620, "treatment_name": "Favipiravir+maraviroc", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |